Seattle Genetics reported that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
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InDex Pharmaceuticals has secured the orphan-drug designation for the drug candidate cobitolimod from the US Food and Drug Administration (FDA) for treatment of ulcerative colitis in pediatric patients.
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Janssen Biotech has received a setback for its rheumatoid arthritis (RA) drug sirukumab after the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) decided not to recommend its approval.
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AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for its Bruton tyrosine kinase (BTK) inhibitor, acalabrutinib.
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The National Institute for Health and Care Excellence (NICE) has turned down Roche’s urothelial cancer drug atezolizumab citing the need for stronger evidence in clinical and cost effectiveness.
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Galera Therapeutics' GC4419 has secured a Promising Innovative Medicines (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the reduction of the duration or incidence of radiation and chemotherapy induced severe oral mucositis in head and neck cancer patients.
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Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
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The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
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